INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR

Set, Administration, Intravascular

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Interlink System Extension Set With Control-a-flo-regulatory Clearlink System Extension Set With Control-a-flo-regulator.

Pre-market Notification Details

Device IDK121634
510k NumberK121634
Device Name:INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORPORATION 25212 W. ILLINOIS ROUTE 120 Round Lake,  IL  60073
ContactNanette Hedden
CorrespondentNanette Hedden
BAXTER HEALTHCARE CORPORATION 25212 W. ILLINOIS ROUTE 120 Round Lake,  IL  60073
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-04
Decision Date2012-06-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412069307 K121634 000
50085412046391 K121634 000
50085412004032 K121634 000
50085412002427 K121634 000

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